Clinical Application of Nutrition Support Package Before Hepatectomy

Liver Neoplasms Clinical Trial

Official title:

Clinical Application of Preoperative Nutritional Support Package for Liver Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218253
• Other study ID #: 20191226
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Chunlei Li, Doctor
• Phone: 18622370261
• Email: lcltjmu507[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.

Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma)

• 2. No contraindications for surgery

• 3. Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state <2 points

• 4. Preoperative liver function score Child-Pugh = 6 points: total bilirubin = 3.0 mg / dl, albumin = 28 g / L, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 5 times the upper limit of normal

• 5. Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher

Exclusion Criteria:

• 1. Patients who took fish oil supplements within 3 weeks before the study began

• 2. Patients with severe nutritional risk: serious nutritional risk should be considered when combining any of the following conditions: weight loss > 10% within 6 months; digital pain score (NRS) score > 5 points; BMI <18.5 kg/m2 (all patients with severe nutritional risk undergo individualized supportive care);

• 3. Patients with malignant tumors in other parts

• 4. Patients who are pregnant or lactating

• 5. Patients with mental and neurological disorders who cannot cooperate with medical staff

• 6. Patients with severe diabetes or poor glycemic control

• 7. Patients cannot tolerate nutritional preparations

• 8. Other circumstances that the researcher considers inappropriate to participate in the study

Related Conditions & MeSH terms

• Hepatectomy
• Liver Neoplasms
• Nutrition Therapy

Intervention

Dietary Supplement:
• 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber
300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA).

Behavioral:
• Dietary mission
Dietary education was conducted according to preoperative nutritional requirements

Locations

Country	Name	City	State
China	Tianjin Medical University cancer Instituteand Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications at 30 days after surgery	Postoperative complications were defined by Clavien-Dindo. Grade 1: Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.; Grade 2: Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.; Grade 3: Requiring surgical, endoscopic, or radiologic intervention 3a: Intervention not under general anesthesia 3b: Intervention under general anesthesia Grade 4:Life-threatening complication (including CNS complications) requiring IC/ICU management.; 4a: Single organ dysfunction (including dialysis) 4b: Multiple organ dysfunction Grade 5: Death as a result of complications	up to 30 days after surgery
Secondary	Postoperative hospital stay	from the date of the operation to the date of discharge	up to 90 days after surgery